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FDA Approves Enstilar Foam

LEO Pharma Announces U.S. Approval of Enstilar Foam (calcipotriene/betamethasone dipropionate) for Plaque Psoriasis

Ballerup, Denmark 19 October, 2015: LEO Pharma announced today that the U.S. Food and Drug Administration (FDA) has approved Enstilar (calcipotriene/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) Foam for the treatment of psoriasis vulgaris in patients 18 years of age or older in the United States.1 Enstilar is a once-daily, alcohol-free topical treatment.1

“We are very pleased by the U.S. approval of Enstilar and believe it will provide patients with the type of treatment option that they are looking for,” said Gitte Aabo, President and CEO of LEO Pharma. “At LEO Pharma, we are committed to providing patients with innovative, new solutions and we believe the foam formulation of Enstilar can help patients living with psoriasis.”

Enstilar was developed to treat patients with psoriasis vulgaris2,3 – the most common clinical form of psoriasis.4

The U.S. approval of Enstilar was based on the Phase 3a PSO-FAST study which evaluated the efficacy and safety profile across a four week period,5 and the Phase 2 MUSE safety profile study.6 In the pivotal Phase 3 PSO-FAST clinical trial, over half of patients treated with Enstilar were “Clear” or “Almost Clear” by Week 4 as measured by the 2-step Investigator Global Assessment (IGA) improvement score.1 Additionally, more than half of patients treated with Enstilar achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline.7

In March 2015, LEO Pharma submitted Marketing Authorisation Applications to 30 European Health Authorities for Enstilar; however, the product is currently only approved for use in the U.S.

About Enstilar

Enstilar combines a vitamin D analogue (calcipotriene) with a potent corticosteroid (betamethasone dipropionate) to achieve a normalizing result on the affected skin cells and promote a greater anti-inflammatory response than the monotherapy components alone in patients suffering from psoriasis vulgaris.

About Psoriasis

Psoriasis is a chronic, inflammatory skin disease, which is frequently accompanied by multiple physical and/or psychological comorbidities, such as metabolic syndrome and psoriatic arthritis.6

Psoriasis is estimated to affect about 2-4% of the population in western countries.8 80% of patients are affected by psoriasis vulgaris – the most common type of psoriasis.4

Topical treatments can be used as first-line therapies for the majority of patients suffering from psoriasis.4

References

  1. Enstilar [prescribing information]. Parsippany, NJ: LEO Pharma Inc.; 2015
  2. Hollesen Basse L, et al. Enhanced in vitro skin penetration and antipsoriatic effect of fixed combination calcipotriene plus betamethasone dipropionate in an innovative foam vehicle. Journal of Investigative Dermatology 2014; 134(S30): abstract 192
  3. Queille-Roussel C, et al. Antipsoriatic effect of a novel aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate in patients with psoriasis, using a modified psoriasis plaque test. Presented at the Fall Clinical Dermatology Conference, Encore, Las Vegas, October 16-19, 2014
  4. Reich K, et al. Efficacy of a fixed combination of with calcipotriene/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicentre, randomized, controlled, prospective study. Journal of European Academy of Dermatology Venereology 2014: October (epub ahead of print) DOI: 10.1111/jdv.12774
  5. LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris. 2013. ClinicalTrials.gov Identifier: NCT01866163.

Source: LEO Pharma

Posted: October 2015

Enstilar (betamethasone dipropionate and calcipotriene) FDA Approval History

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